A Randomized, Double-Blind Phase I Study to Evaluate Topically Applied WBI-1001 Cream in Patients With Psoriasis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Evaluate safety and tolerability of topically applied WBI-1001 cream, and to assess the pharmacokinetics based on plasma concentrations
研究概览
简要总结
The purpose of this study is to evaluate primarily the safety and tolerability and secondarily the efficacy of topically applied WBI-1001 cream in patients with mild to moderate psoriasis. Double-blind, randomized, placebo controlled study of 36 patients, treated for 28 days plus a 7 day follow-up.in which the patients were divided into six cohorts: Cohort 1 at 0.5% QD;Cohort 2 at 0.5% BID; Cohort 3 at 1.0% QD; Cohort 4 at 1.0% BID; Cohort 5 at 2.0% QD; Cohort 6 at 2.0% BID.Efficacy assessed by PGA,target lesion assessment and BSA. Safety assessed through vital signs, ECG, AEs and Plasma PK via Cmin, Cmax,Tmax and AUCo-t.
详细描述
Patients initiated screening within 4 weeks of commencing study treatment. Based on progression of the study, at day 0 patients were assigned to one of six treatment Cohorts. Patients were randomized to treat all areas except the face, scalp, groin and genital areas. Patients in Cohort 1 were treated on one side with a thin layer of active cream and the other with placebo; in the absence of significant AEs by 14 days after the last treatment in the Cohort escalation to the next Cohort was allowed, and each Cohort respectively.
During the treatment period patients visited the study centre weekly for safety, tolerability and efficacy assessment. On these study visit days blood draws were done between 7.00 and 10.00am prior to that morning's application of cream.
The study enrolled healthy male and female patients aged 18-65 y.o. with clinical diagnosis of stable plaque psoriasis for >months affecting a maximum of 6% of BSA with a minimum of 0.5% BSA on each side of the body and a minimum of one plaque at least 2x2 cm on each side excluding elbow and knee.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PGA score at day 0 must be 2,3 or
- •In good overall health.
- •Women of child bearing potential to have negative serum beta-human chorionic gonadotropin pregnancy test before randomization
- •Must be prepared to use adequate means of contraception
- •Must not be lactating.
- •Male partners of females in the study must be prepared to use adequate means of contraception.
- •Must comply with study protocol and attend all visits.
- •Provide written consent prior to participating in the study.
排除标准
- •Spontaneously improving or rapidly deteriorating psoriasis.
- •Patients with other diseases (especially dermatological, immunodeficiency or neurological/psychiatric) that might interfere with assessment of plaque psoriasis.
- •Systemic immunomodulatory therapy in past 36 weeks, phototherapy in past 4 weeks, various psoriatic chemotherapies and beta blockers in the past 2 weeks
结局指标
主要结局
Evaluate safety and tolerability of topically applied WBI-1001 cream, and to assess the pharmacokinetics based on plasma concentrations
时间窗: 35 days
次要结局
- Obtain initial evaluation of efficacy of topically applied WBI-1001 cream in patients with mild to moderate psoriasis.(35 days)